U.S. patent application number 13/093352 was filed with the patent office on 2012-10-25 for aspiration thrombectomy device.
Invention is credited to Sony Agrawal.
Application Number | 20120271231 13/093352 |
Document ID | / |
Family ID | 47021880 |
Filed Date | 2012-10-25 |
United States Patent
Application |
20120271231 |
Kind Code |
A1 |
Agrawal; Sony |
October 25, 2012 |
ASPIRATION THROMBECTOMY DEVICE
Abstract
A thrombectomy system to remove thrombus accumulation from a
space between a body valve and a wall of a body vessel is described
herein. The system can have a thrombectomy catheter having a lumen
therein. The thrombectomy catheter can include a first occlusion
member disposed circumferentially around a distal end thereof. An
occlusion catheter can be disposed within the lumen of the
thrombectomy catheter and can have a second occlusion member
disposed at a distal end thereof. The first and second occlusion
members can be expanded to occlude the body vessel to isolate a
region thereof. An aspiration catheter can be disposed within the
lumen of the thrombectomy catheter and can have an articulable
nozzle at a distal end thereof. The articulable nozzle can be
extended beyond a distal end opening of the thrombectomy catheter
to aspirate a thrombus accumulation from within the isolated region
of the body vessel.
Inventors: |
Agrawal; Sony; (Bloomington,
IN) |
Family ID: |
47021880 |
Appl. No.: |
13/093352 |
Filed: |
April 25, 2011 |
Current U.S.
Class: |
604/101.01 |
Current CPC
Class: |
A61B 2017/22067
20130101; A61B 2017/00783 20130101; A61B 2017/22072 20130101; A61B
2017/22054 20130101; A61B 2017/22079 20130101; A61B 2017/22094
20130101; A61B 17/22 20130101 |
Class at
Publication: |
604/101.01 |
International
Class: |
A61B 17/22 20060101
A61B017/22 |
Claims
1. An aspiration thrombectomy system comprising: a thrombectomy
catheter having a proximal end, a distal end, a thrombectomy lumen
extending longitudinally therethrough between the proximal and
distal ends of the thrombectomy catheter, and a first occlusion
member movable between a non-expanded configuration and an expanded
configuration to sealably engage an interior wall of a body vessel;
an occlusion catheter having a proximal end, a distal end, an
occlusion lumen extending longitudinally therethrough between the
proximal and distal ends of the occlusion catheter, and a second
occlusion member moveable between a non-expanded configuration and
an expanded configuration to sealably engage the interior wall of
the body vessel, the occlusion catheter slidably received within
the thrombectomy lumen of the thrombectomy catheter; and an
aspiration catheter having a proximal end, a distal end, an
aspiration lumen extending longitudinally therethrough between the
proximal and distal ends of the aspiration catheter, and at least
one articulable nozzle at the distal end thereof, the aspiration
catheter disposed within the thrombectomy lumen of the thrombectomy
catheter; wherein the second occlusion member is extendable
distally away from the first occlusion member by a longitudinal
distance to isolate a region of the body vessel when the first and
second occlusion members are in the expanded configurations, and
wherein the at least one articulable nozzle is extendable external
to the thrombectomy catheter to aspirate the isolated region of the
body vessel.
2. The system of claim 1, wherein the occlusion catheter further
comprises at least one nozzle port formed therein, the aspiration
catheter is disposed within the occlusion lumen of the occlusion
catheter, and the at least one articulable nozzle is extendable
through the at least one nozzle port to aspirate the isolated
region of the body vessel.
3. The system of claim 2, wherein the aspiration catheter comprises
a first aspiration lumen and a second aspiration lumen each
extending longitudinally therein, the at least one articulable
nozzle comprises a first articulable nozzle and a second
articulable nozzle, and the first articulable nozzle is in
communication with the first aspiration lumen and the second
articulable nozzle is in communication with the second aspiration
lumen; and wherein the at least one nozzle port of the occlusion
catheter comprises a first nozzle port and a second nozzle port and
the first articulable nozzle is extendable through the first nozzle
port and the second articulable nozzle is extendable through the
second nozzle port.
4. The system of claim 3, wherein the first and second nozzle ports
are disposed 180 degrees apart from one another.
5. The system of claim 1, wherein the aspiration catheter is
disposed adjacent to the occlusion catheter within the thrombectomy
lumen of the thrombectomy catheter, and the at least one
articulable nozzle is extendable beyond a distal end opening of the
thrombectomy catheter to aspirate the isolated region of the body
vessel.
6. The system of claim 5, wherein the aspiration catheter is
configured to move 360 degrees around the occlusion catheter within
an annular space defined between the thrombectomy catheter and the
occlusion catheter.
7. The system of claim 5, wherein the aspiration catheter comprises
a first aspiration lumen and a second aspiration lumen, the at
least one articulable nozzle comprises a first articulable nozzle
and a second articulable nozzle, and the first articulable nozzle
is in communication with the first aspiration lumen and the second
articulable nozzle is in communication with the second aspiration
lumen.
8. The system of claim 1, wherein the distal end of the
thrombectomy catheter is disposed between the first and second
occlusion members such that the isolated region of the body vessel
is accessible through a distal end opening of the thrombectomy
catheter.
9. The system of claim 1, wherein the first and second occlusion
members are inflatable balloons.
10. The system of claim 1, wherein the aspiration catheter further
comprises a means for manipulating the at least one articulable
nozzle thereof.
11. An aspiration thrombectomy system comprising: a thrombectomy
catheter having a proximal end, a distal end, a thrombectomy lumen
extending longitudinally therein, and a first occlusion member
disposed around an outer circumference of the distal end thereof,
wherein the first occlusion member is movable between a
non-expanded configuration and an expanded configuration; an
occlusion catheter having a proximal end, a distal end, a second
lumen extending longitudinally therein, and a second occlusion
member disposed at the distal end thereof, wherein the second
occlusion member is moveable between a non-expanded configuration
and an expanded configuration, and the occlusion catheter is
slidably received within the thrombectomy lumen of the thrombectomy
catheter and spaced therefrom to define an annular space; and an
aspiration catheter having a proximal end, a distal end, an
aspiration lumen extending longitudinally therein, and at least one
articulable nozzle at the distal end thereof, the aspiration
catheter disposed within the thrombectomy lumen of the thrombectomy
catheter adjacent to the occlusion catheter, and the at least one
articulable nozzle extendable beyond a distal end opening of the
thrombectomy catheter; wherein the second occlusion member is
extendable distally away from the first occlusion member by a
longitudinal distance to isolate a region of the body vessel when
the first and second occlusion members are in the expanded
configurations, the at least one articulable nozzle is extendable
external to the thrombectomy catheter to aspirate the isolated
region of the body vessel, and the aspiration catheter is moveable
circumferentially within the annular space between the thrombectomy
catheter and the occlusion catheter.
12. The system of claim 11, wherein the aspiration catheter
comprises a first aspiration lumen and a second aspiration lumen
each extending longitudinally therein, the at least one articulable
nozzle comprises a first articulable nozzle and a second
articulable nozzle, and the first articulable nozzle is in
communication with the first aspiration lumen and the second
articulable nozzle is in communication with the second aspiration
lumen.
13. The system of claim 11, wherein the aspiration catheter
comprises a first tubular member and a second tubular member each
tubular member having a lumen extending longitudinally therein, and
the at least one articulable nozzle comprises a first articulable
nozzle and a second articulable nozzle, wherein a nozzle lumen of
the first articulable nozzle is in communication with the lumen of
the first tubular member and a nozzle lumen of the second
articulable nozzle is in communication with the lumen of the second
tubular member.
14. The system of claim 11, wherein the aspiration catheter further
comprises a means for manipulating the at least one articulable
nozzle thereof.
15. A method for removing thrombus accumulation from a body vessel,
the method comprising: introducing a thrombectomy catheter within
the body vessel, and introducing an occlusion catheter within the
body vessel; expanding a first occlusion member of the thrombectomy
catheter to an expanded configuration to engage a wall of the body
vessel; positioning a second occlusion member of the occlusion
catheter distal to the first occlusion member; expanding the second
occlusion member to an expanded configuration to isolate a region
of the body vessel between the first and second occlusion members;
introducing at least one articulable nozzle of an aspiration
catheter within the isolated region of the body vessel between the
expanded first and second occlusion members; extending the at least
one articulable nozzle to a position proximate a thrombus
accumulation; and aspirating the thrombus accumulation through an
aspiration lumen of the aspiration catheter to remove the thrombus
accumulation from the body vessel.
16. The method of claim 15, further comprising introducing the
occlusion catheter and the aspiration catheter within a
thrombectomy lumen of the thrombectomy catheter, and extending the
at least one aspiration nozzle of the aspiration catheter beyond a
distal end opening of the thrombectomy catheter to aspirate the
thrombus accumulation from the isolated region of the body
vessel.
17. The method of claim 16, wherein the occlusion catheter and the
aspiration catheter are adjacent to one another within the
thrombectomy lumen of the thrombectomy catheter.
18. The method of claim 16, wherein the occlusion catheter further
comprises an occlusion lumen extending longitudinally therein and
at least one nozzle side port formed therein, the method further
comprising introducing the aspiration catheter within the occlusion
lumen of the occlusion catheter and extending the at least one
aspiration nozzle through the at least one nozzle side port to
aspirate the thrombus accumulation from the isolated region of the
body vessel.
19. The method of claim 15, wherein the body vessel further
comprises a valve member, the method further comprising positioning
the first and second occlusion members at opposite sides of the
valve member, and aspirating the thrombus accumulation disposed
between the valve member and the wall of the body vessel.
20. The method of claim 15, further comprising manipulating the at
least one articulable nozzle between a neutral configuration and a
bending configuration to position an end opening of the articulable
nozzle proximate the thrombus accumulation.
Description
BACKGROUND
[0001] The present disclosure relates generally to medical devices.
More particularly, it relates to thrombectomy devices for removing
thrombus deposits from a space between a body valve and a wall of a
body vessel.
[0002] Vascular disease affects a large proportion of individuals
each year. One indication of the existence of this disease is the
development of a blood clot in the vascular system, which if left
untreated may result in deep vein thrombosis, embolisms, or
ischemia. Thrombi within the vasculature can form as a result of a
variety of causes, such as trauma, disease, surgery, stagnant
blood, and foreign devices in the vasculature. These clots are
usually comprised of an aggregated mixture of thrombus and fibrin.
Typically, a thrombus present in an arterial blood vessel tends to
migrate in the direction of flow from a large diameter artery to
smaller diameter arteries. The thrombus continues to flow with the
blood until it becomes lodged against the vessel wall and is unable
to advance. In some instances, the thrombus partially or completely
blocks blood flow through the artery thereby preventing blood from
reaching the tissue disposed downstream of the thrombus. Denying
blood flow for an extended period of time can result in damage or
death of the tissue beyond the blockage. The result can be loss of
toes or fingers, or even an entire limb in more severe
circumstances. Moreover, thrombi in the venous system can migrate
to the lungs and become a pulmonary embolus, which is usually
fatal. In other instances, thrombi can migrate into the cerebral
circulation and cause stroke and death.
[0003] Various known techniques for the removal of blood clots
include both chemical and mechanical treatment. Chemical treatment
typically involves the injection of lysine agents into the vessel
near the blood clot to chemically attack, dissolve, and disperse
the occlusion. In this technique, the lysine agent is brought into
the proximate vicinity of the blood clot by injection through a
cannula or other lumen.
[0004] The mechanical treatment of a blood clot typically involves
the use of catheters having a rotary cutting head or other form of
a rotor-stator homogenizing head. Examples of such rotary devices
include rotating burr devices, devices with a rotating helical coil
wire within a catheter, and recanalization catheters. Other
mechanical devices utilize a balloon that is inflated in a vessel
and then withdrawn to pull a clot into a conventional sheath. The
sheath may then be withdrawn from the patient to remove the
captured clot or the clot may be aspirated into the sheath and
removed from the patient. Still other mechanical devices utilize a
sharp point to pierce the occlusion to form a hole therethrough. In
each of these cases, although the occlusion is reduced in size or a
passageway is created, the residual thrombus/fibrin material
resulting from the treatment remains within the vessel.
[0005] Although these treatment devices and methods may be adequate
to remove the majority of a clot, they do not effectively remove
the residual material formed during fragmentation of a blood clot
or the accumulation of thrombus material disposed in the space
between a body valve and a body vessel wall. Removal of such
residual material and/or accumulated material is medically
desirable. It is further necessary to ensure that this residual
material and/or accumulated material does not migrate away from the
site of the treatment to other parts of the vessel. Such migration
could lead to serious complications, such as embolism, stroke, or
heart attack.
[0006] Thus, what is needed is a device for removing the thrombus
material from a space between a body valve and a body vessel wall.
It would be desirable if such device is easy for a physician to use
and compatible with existing thrombectomy methods.
SUMMARY
[0007] Accordingly, a thrombectomy system is provided herein to
address at least some of the shortcomings of the prior art. The
system can be used for removing a thrombus accumulation from a
space between a body valve and the wall of a body vessel. In one
example, the system can include a thrombectomy catheter having a
proximal end, a distal end, and a thrombectomy lumen extending
longitudinally therein. A first occlusion member can be disposed
around an outer circumference of the distal end of the thrombectomy
catheter. The first occlusion member can be moveable between a
non-expanded configuration and an expanded configuration to engage
the wall of the body vessel. The system further can include an
occlusion catheter having a proximal end, a distal end, and an
occlusion lumen extending longitudinally therein. The occlusion
catheter can be disposed within the thrombectomy lumen of the
thrombectomy catheter. A second occlusion member can be disposed at
the distal end of the occlusion catheter. The second occlusion
member can be moveable between a non-expanded configuration and an
expanded configuration to engage the wall of the body vessel. The
system further can include an aspiration catheter having a proximal
end, a distal end, and an aspiration lumen extending longitudinally
therein. The aspiration catheter can be disposed within the
thrombectomy lumen of the thrombectomy catheter. An articulable
nozzle can be disposed at the distal end of the aspiration
catheter. The second occlusion member of the occlusion catheter can
be extendable distally away from the first occlusion device by a
distance such that, when the first and second occlusion members are
expanded to engage the wall of the body vessel, a section of the
body vessel can be isolated. The articulable nozzle of the
aspiration catheter can extend beyond an end opening of the
thrombectomy catheter to aspirate thrombus material from the
isolated region of the body vessel.
[0008] In another example, a method of removing a thrombus
accumulation from a body vessel is provided herein. A thrombectomy
catheter and an occlusion catheter can be introduced into the body
vessel. A first occlusion member of the thrombectomy catheter can
be expanded from a non-expanded configuration to an expanded
configuration to engage a wall of the body vessel. A second
occlusion member of the occlusion catheter can be positioned distal
to the first occlusion member of the thrombectomy catheter. The
second occlusion member can be expanded from the non-expanded
configuration to the expanded configuration to engage the wall of
the body vessel. A region of the body vessel extending between the
first and second occlusion members may be isolated thereby. An
aspiration catheter can be introduced into the body vessel. At
least one articulable nozzle of the aspiration catheter can be
positioned within the isolated region of the body vessel. The
articulable nozzle can be extended to a position between the first
and second occlusion members and proximate a thrombus accumulation.
The thrombus accumulation can be aspirated through the aspiration
catheter to remove the thrombus accumulation from the body
vessel.
BRIEF DESCRIPTIONS OF THE DRAWINGS
[0009] FIG. 1a is a perspective view of one example of a
thrombectomy system.
[0010] FIG. 1b is a perspective view of one example of an
articulable nozzle.
[0011] FIG. 1c is a cross-sectional view of the thrombectomy system
illustrated in FIG. 1a.
[0012] FIG. 2 is a perspective view of another example of a
thrombectomy system.
[0013] FIG. 3 is a perspective view of another example of an
aspiration catheter having multiple articulable nozzles.
[0014] FIGS. 4a-4h illustrate a method of aspirating an isolated
region of a body vessel.
DETAILED DESCRIPTION OF THE DRAWINGS AND THE PRESENTLY PREFERRED
EMBODIMENTS
[0015] For the purposes of promoting an understanding of the
principles of the present disclosure, reference will now be made to
the embodiments illustrated in the drawings, and specific language
will be used to describe the same. It should nevertheless be
understood that no limitation of the scope of the invention is
thereby intended, such alterations and further modifications in the
illustrated apparatus, and such further applications of the
principles of the invention as illustrated therein being
contemplated as would normally occur to one skilled in the art to
which the invention relates. In the following discussion, the terms
"proximal" and "distal" will be used to describe the opposing axial
ends of the system, as well as the axial ends of various component
features. The "proximal" end refers to the end of the system (or
component thereof) that is closest to the operator during use of
the system. The "distal" end refers to the end of the system (or
component thereof) that is initially inserted into the patient, or
that is closest to the patient. The term "catheter" shall have its
plain and ordinary meaning, rather than any lexicographic
definition. Given the configuration of a vessel passageway or the
channel of an endoscope or accessory device, a variety of catheters
of different shapes and sizes can be used depending on the
particular medical applications for the catheter. The term
"tubular" includes any tube-like, cylindrical, elongated,
shaft-like, rounded, oblong, or other elongated longitudinal
shaft.
[0016] Generally speaking, the present disclosure is directed to a
thrombectomy system. The system may be used for removing any sort
of material that may be partially or completely occluding a body
vessel. Such occlusions may be caused by, for example, emboli,
plaque, or thrombi. The system may be particularly useful for
aspirating thrombus material from an isolated portion of a blood
vessel such as an artery or a vein. Such an isolated portion of a
blood vessel may include a valve member, such as a coronary or
venous valve. In one example, the system may be useful for removing
thrombus accumulation disposed in a space between such a valve
member and an interior wall of the body vessel. Other applications
for the system will become readily apparent to one skilled in the
art from the detailed description.
[0017] FIGS. 1a-1c depict one embodiment of a thrombectomy system
10 having a thrombectomy catheter 20, an occlusion catheter 40, and
an aspiration catheter 60. The thrombectomy catheter 20 can include
a generally tubular body 21 having a proximal end and a distal end
23. The proximal end of the thrombectomy catheter 20 may include a
handle having an adapter configured to receive the occlusion
catheter and/or the aspiration catheter as further described
herein. The occlusion catheter and/or the aspiration catheter may
be received within a common adapter or within multiple adapters. An
additional adapter (e.g., a Luer lock adapter) may be included to
engage a device for applying negative pressure as further described
herein. The proximal end of the thrombectomy catheter 20 may be
configured as a catheter hub such as that described in U.S. Pat.
No. 7,713,260 to Lessard et al., which is incorporated by reference
herein in its entirety.
[0018] The tip of the distal end 23 may have a planar, flat,
rounded, chamfered, distally tapered, or arrow-head shape, or may
be otherwise atraumatically shaped, to minimize trauma to the body
vessel and/or pain and discomfort during introduction and/or
navigation of the thrombectomy catheter 20 within the body of the
patient. A thrombectomy lumen 24 can extend longitudinally within
the thrombectomy catheter 20 between the proximal end and the
distal end 23. The thrombectomy lumen 24 can be in communication
with an end opening 25 at the distal end 23 of the thrombectomy
catheter 20. The end opening 25 can allow access to an isolated
portion of a body vessel as further described herein. The
thrombectomy catheter 20 can have a size and shape suitable for
insertion and placement within a body vessel such as an artery or a
vein. For example, the thrombectomy catheter 20 may have an outer
diameter of from about 9 to about 15 French (Fr) and a length of
from about 70 to about 110 centimeters (cm).
[0019] The thrombectomy catheter 20 further can include a first
occlusion member 26 disposed about a portion of the distal end 23
thereof The first occlusion member 26 can surround an outer
circumference of the body 21 of the thrombectomy catheter 20. The
body 21 of the thrombectomy catheter 20 can extend at least to a
distal end of the first occlusion member 26 such that the end
opening 25 can be disposed in a position distal of the first
occlusion member 26. Optionally, the body 21 may extend further
distally beyond the first occlusion member 26 as shown in FIG. 1a.
This arrangement can permit the thrombectomy lumen 24 to extend
distally beyond the first occlusion member 26 to provide access to
the isolated portion of the body vessel through the end opening 25.
The first occlusion member 26 can be moveable between a
non-expanded configuration and an expanded configuration to
sealably engage an inner wall 101 of a body vessel 100. In the
expanded configuration, the first occlusion member 26 preferably
can fill an entire space between the thrombectomy catheter 20 and
the inner wall 101 of the body vessel 100 to substantially inhibit
any fluid from flowing within the body vessel. In other words, the
first occlusion member 26 and the thrombectomy catheter 20 may
substantially fill an entire cross section of the body vessel 100.
The first occlusion member 26 can be any type of occlusion and/or
embolization device known in the art.
[0020] The body 21 of the thrombectomy catheter 20 can be formed
from any appropriate material known in the art. Preferably, the
body 21 can be formed from a conventional pliable radiopaque
plastic. Non-limiting examples of suitable materials include
polytetrafluoroethylene (PTFE), polyurethane, fluoroplastic,
polyester, nylon, polypropylene, and silicone plastic.
Additionally, the first occlusion member 26 can be made of any
appropriate flexible material known in the art. Non-limiting
examples of such a material include nylon, polyester, polyurethane,
PTFE, latex, rubber, silicone plastic, and mixtures thereof The
first occlusion device can be attached to the body 21 of the
thrombectomy catheter 20 by any suitable means known in the art,
such as for example, hot melt bonding, adhesive bonding, solvent
bonding, or ultrasonic welding. In one example, the first occlusion
member 26 can be an expandable support structure covered by an
impermeable membrane. In another example, the first occlusion
member 26 can be an inflatable balloon as shown in FIG. 1a. One
example of a suitable inflatable balloon is described in U.S. Pat.
App. Pub. No. 2010/0036314 to Burton et al., incorporated by
reference herein in its entirety. To that end, the thrombectomy
catheter 20 further can include an inflation tube (not shown)
extending longitudinally along a length of the thrombectomy
catheter between the proximal end and the distal end 23. The
inflation tube can have an inflation lumen extending longitudinally
therein and being in fluid communication with an interior volume of
the inflatable balloon. The inflation tube may be disposed along
the interior of the body 21 of the thrombectomy catheter 20 within
the thrombectomy lumen 24. Alternatively, the inflation tube may be
disposed along the exterior of the body 21 in abutting contact with
an outer surface of the body of the thrombectomy catheter 20. The
inflatable balloon can be inflated and/or deflated by supplying
and/or withdrawing an inflation fluid through the inflation lumen
at the proximal end of the thrombectomy catheter as is well known
in the art. One example of a suitable balloon inflation lumen
configuration is described in U.S. Pat. No. 7,578,295 to Kurrus,
incorporated by reference herein in its entirety.
[0021] The occlusion catheter 40 can include a generally tubular
body 41 having a proximal end and a distal end 43. The tip of the
distal end 43 may have a planar, flat, rounded, chamfered, distally
tapered, or arrow-head shape, or may be otherwise atraumatically
shaped to minimize trauma to the body vessel and/or pain and
discomfort during introduction and/or navigation of the occlusion
catheter 40 within the body of the patient. The body 41 of the
occlusion catheter 40 can be formed from any suitable material
known in the art as described in reference to the thrombectomy
catheter 20. The body 41 of the occlusion catheter 40 can be formed
from the same or a different material than that used to form the
body 21 of the thrombectomy catheter 20. An occlusion lumen 44 can
extend longitudinally within the occlusion catheter 40 between the
proximal end and the distal end 43. The occlusion catheter 40 can
have a size and shape suitable for insertion and placement within a
body vessel such as an artery or vein. More specifically, the
occlusion catheter 40 can have a size and shape suitable for
insertion through the thrombectomy lumen 24 of the thrombectomy
catheter 20 as further described herein. For example, the occlusion
catheter 40 may have an outer diameter of from about 5 to about 7
Fr and a length of from about 70 to about 110 cm.
[0022] The occlusion catheter 40 further can include a second
occlusion member 45 disposed at the distal end 43 thereof. The
second occlusion member 45 can be moveable between a non-expanded
configuration and an expanded configuration to contact the inner
wall 101 of the body vessel 100. In the expanded configuration, the
second occlusion member 45 of the occlusion catheter 40 preferably
can fill an entire cross section of the body vessel 100 to
substantially inhibit any fluid from flowing within the body
vessel. The second occlusion member 45 can be any type of occlusion
and/or embolization device known in the art. For example, the
second occlusion member 45 can be an inflatable balloon as shown in
FIG. 1a. To that end, the occlusion catheter 40 can include an
inflation lumen (not shown) extending longitudinally along a length
of the occlusion catheter 40 between the proximal end and the
distal end 43. The occlusion lumen 44 may serve as the inflation
lumen. Alternatively, the inflation lumen may extend longitudinally
within an inflation tube (not shown) that can be disposed along the
interior or exterior of the body of the occlusion catheter. The
inflation lumen can be in fluid communication with an interior
volume of the inflatable balloon. The second occlusion member 45
can be inflated, and/or deflated by supplying and/or withdrawing an
inflation fluid through the inflation lumen at the proximal end of
the occlusion catheter as is well known in the art and described
herein with respect to the first occlusion member 26. The second
occlusion member 45 can be formed from any appropriate flexible
material known in the art as described herein. The second occlusion
member 45 may be formed from the same or a different material than
that used to form the first occlusion member 26. The second
occlusion member 45 can be attached to the body 41 of the occlusion
catheter 40 by any suitable means known in the art as described
herein.
[0023] The occlusion catheter 40 can be slidably received within
the thrombectomy lumen 24 of the thrombectomy catheter 20. The
thrombectomy catheter 20 and the occlusion catheter 40 may be
coaxial. The distal end 43 of the occlusion catheter 40 can be
extendable through the end opening 25 and distally away from the
distal end 23 of the thrombectomy catheter 20 by a distance A. The
distance A can be dimensioned such that a region 102 of the body
vessel 100 can be isolated by expanding the first and second
occlusion members 26, 45 to the expanded configuration as further
described herein. Fluid flow through the body vessel 100 may be
substantially inhibited when either of the first and second
occlusion members 26, 45 is in the expanded configuration. When
both the first and second occlusion members 26, 45 are in the
expanded configuration, fluid communication between the isolated
region 102 and other portions of the body vessel 100, either
upstream or downstream of the isolated region, may be substantially
inhibited.
[0024] The aspiration catheter 60 can include a generally tubular
body 61 having a proximal end and a distal end 63. The body 61 of
the aspiration catheter 60 can be made of any suitable material
known in the art as described herein with respect to the
thrombectomy catheter 20. An aspiration lumen 64 can extend
longitudinally within the aspiration catheter 60 between the
proximal end and the distal end 63. The aspiration catheter 60 can
have a size and shape suitable for insertion and placement within a
body vessel such as an artery or a vein. More specifically, the
aspiration catheter 60 can have a size and shape suitable for
insertion through the thrombectomy lumen 24 of the thrombectomy
catheter 20 and/or the occlusion lumen 44 of the occlusion catheter
40 as further described herein. For example, the aspiration
catheter 60 may have an outer diameter of from about 5 to about 7
Fr and a length of from about 70 to about 110 cm.
[0025] The aspiration catheter 60 further can include at least one
articulable nozzle 65 disposed at the distal end 63 thereof. The
articulable nozzle 65 can be capable of articulating as further
described herein. In other words, the articulable nozzle 65 can be
movable by, for example, rotation, bending, and/or translational
displacements along any three dimensional direction. For instance,
such articulation may be axial, longitudinal, forward, backward,
orthogonal, lateral, transverse, rotational, pivotable, sloping
incline or decline, swinging, torsional, revolving, and/or other
forms of translation and/or rotation relative to a coordinate
system. A first coordinate system is shown in FIG. 1c where the
z-axis is the longitudinal axis of the thrombectomy catheter 20,
and the x-axis and the y-axis are substantially perpendicular to
the z-axis and to each other. A second coordinate system parallel
to the first coordinate system is shown in FIG. 1c where the c-axis
is the longitudinal axis of the aspiration catheter 60, and the
a-axis and the b-axis are substantially perpendicular to the c-axis
and to each other. Arrows illustrate that the aspiration catheter
can be rotated about the c-axis, as well as moved longitudinally
along the c-axis, and in any direction along the x-axis and/or the
y-axis within the annular space defined between the thrombectomy
catheter 20 and the occlusion catheter 40.
[0026] The articulable nozzle 65 can be formed from any suitable
material known in the art. Preferably, such a material can be
strong yet sufficiently flexible and resilient to allow
articulation of the articulable nozzle 65 as described herein.
Non-limiting examples of such materials include elastomeric
materials such as latex, silicone, urethane, thermoplastic
elastomer, nickel titanium alloy, polyether etherketone (PEEK),
polyimide, polyurethane, cellulose acetate, cellulose nitrate,
polyethylene terephthalate (PET), polyamide, polyester,
polyorthoester, polyanhydride, polyether sulfone, polycarbonate,
polypropylene, high molecular weight polyethylene, PTFE, or
mixtures or copolymers thereof, polylactic acid, polyglycolic acid
or copolymers thereof, polycaprolactone, polyhydroxyalkanoate,
polyhydroxy-butyrate valerate, polyhydroxy-butyrate valerate, or
another polymer or suitable material. Optionally, the articulable
nozzle 65 may be formed from an anisotropic material that can be
relatively compliant in an axial direction as compared to a
transverse direction as opposed to an isotropic material that can
be relatively uniformly compliant independent of direction.
[0027] The articulable nozzle 65 can include a nozzle lumen 66 and
an end opening 67. The nozzle lumen 66 can be in communication with
the aspiration lumen 64 of the aspiration catheter 60. The
articulable nozzle 65 can be moveable between a neutral
configuration and any number of bending configurations (one such
bending configuration shown in phantom lines) as shown in FIG. 1b.
There may be a number of bending configurations along a continuum
from the neutral configuration to a maximum articulation allowable
by the articulable nozzle 65. In the neutral configuration, the
articulable nozzle 65 can be substantially coaxial with the
aspiration catheter 60 such that the end opening 67 of the
articulable nozzle can be disposed along the longitudinal c-axis of
the aspiration catheter and can face in a distal direction with
respect to the body 61 of the aspiration catheter. In a bending
configuration, the articulable nozzle 65 can be deflected such that
the end opening 67 of the articulable nozzle can be disposed
adjacent to the longitudinal c-axis of the aspiration catheter 60
and can face in a direction other than distally with respect to the
body 61 of the aspiration catheter.
[0028] The aspiration catheter 60 further can include a means for
manipulating the articulable nozzle 65. One example of a suitable
means for manipulating the articulable nozzle 65 can include a
control wire 72 as shown in FIG. 1b. The control wire 72 can extend
longitudinally along a length of the aspiration catheter 60 and the
articulable nozzle 65 between the proximal end of the aspiration
catheter and the end of the articulable nozzle. The control wire 72
can be slidably received within the aspiration lumen 64 of the
aspiration catheter 60. Alternatively, the control wire 72 can be
slidably received within a control wire lumen 73 of a control wire
tube 74 . The control wire tube 74 can be disposed along the
interior of the aspiration catheter 60. Alternatively, the control
wire tube 74 can be disposed along the exterior and adjacent to the
aspiration catheter 60 such that the control wire tube is in
abutting contact with an exterior surface of the aspiration
catheter. The control wire 72 can be fixedly attached to at least a
portion (e.g., the distal end) of the articulable nozzle 65
proximate the end opening 67. A control wire sleeve 75 can extend
along a portion of the articulable nozzle 65. The control wire 72
can be slidably received within a lumen 76 of the control wire
sleeve 75. The control wire sleeve may be configured to lengthen
and shorten with the articulable nozzle 65 during articulation as
further described herein. The control wire 72 can be a flexible
wire made of any suitable material known in the art. Non-limiting
examples of such material include biocompatible metal such as
stainless steel (e.g., 316 L SS), titanium, tantalum, and nitinol;
and high-strength polymer. With the articulable nozzle 65 in the
neutral configuration, advancing the control wire 72 proximally
with respect to the aspiration catheter 60 can cause a longitudinal
segment of the articulable nozzle abutting or proximate to the
control wire to elongate longitudinally in a lengthwise direction.
Such selective elongation of the longitudinal segment can cause the
articulable nozzle 65 to articulate toward a bending configuration
(as shown in phantom lines in FIG. 1b). Conversely, retracting the
control wire 72 distally can cause the longitudinal segment to
shorten longitudinally in a lengthwise direction, thereby causing
the articulable nozzle 65 to articulate back toward the neutral
configuration.
[0029] Another example of a suitable means for manipulating the
articulable nozzle 65 can include at least one control channel (not
shown). The control channel can extend longitudinally along a
length of the aspiration catheter 60 and the articulable nozzle 65
between the proximal end of the aspiration catheter and the distal
end of the articulable nozzle. Preferably, the control channel can
be disposed within, or formed within, outer walls of the body 61 of
the aspiration catheter 60 and a body of the articulable nozzle 65.
Alternatively, the control channel lumen can extend longitudinally
within a distinct control channel tube. The control channel can be
configured to elongate longitudinally in a lengthwise direction in
response to an increased pressure applied to the control channel
Such elongation can cause a longitudinal segment of the articulable
nozzle 65 abutting or proximate to the control channel to elongate
longitudinally in a lengthwise direction. Such selective elongation
of the longitudinal segment can cause the articulable nozzle 65 to
articulate toward a bending configuration. Conversely, the control
channel can be configured to shorten longitudinally in a lengthwise
direction in response to a decreased pressure applied to the
control channel Such shortening can cause the longitudinal segment
to shorten longitudinally in a lengthwise direction, thereby
causing the articulable nozzle 65 to articulate back toward the
neutral configuration. One example of a suitable means for
manipulating the articulable nozzle 65 is described in U.S. Pat.
No. 7,608,056 to Kennedy, II, which is incorporated by reference
herein in its entirety.
[0030] In FIG. 1a, the aspiration catheter 60 can be slidably
received within the thrombectomy lumen 24 of the thrombectomy
catheter 20. The aspiration catheter 60 can be disposed adjacent to
the occlusion catheter 40 within the thrombectomy lumen 24 of the
thrombectomy catheter 20 in a side-by-side configuration. The
distal end 63 of the aspiration catheter 60 can be extendable
through the end opening 25 and distally away from the distal end 23
of the thrombectomy catheter 20 to be positioned for aspiration of
thrombus or other occlusive material from the isolated region 102
of the body vessel 100 as further described herein. Additionally,
the aspiration catheter 60 can be free to move within the
thrombectomy lumen 24 of the thrombectomy catheter 20 in the
annular space between the occlusion catheter 40 and the
thrombectomy catheter 20, as shown in FIG. 1c, for more efficient
access to various portions of the isolated region 102 of the body
vessel 100. For example, the aspiration catheter 60 can be free to
translate axially in the annular space between the occlusion
catheter 40 and the thrombectomy catheter 20 up to 360 degrees
around the occlusion catheter, translated longitudinally in
proximal and/or distal directions, and/or rotated about a
longitudinal axis of the aspiration catheter. Additionally, the
articulable nozzle 65 can be articulated as described herein to
reach any portion of the isolated region 102 of the body vessel
100.
[0031] One of ordinary skill in the art will appreciate that the
dimensions of the various components described herein will depend
on various factors. These factors include the intended use of the
system and the body vessel into which the components of the system
may be positioned. In general, however, each of the thrombectomy
catheter 20, the occlusion catheter 40, and the aspiration catheter
60 can be elongate, meaning that the catheter can be relatively
long enough to reach a target site at a region within the body of
the patient. The overall length of each catheter may vary greatly,
however, depending on the intended medical procedure to be
performed and/or the location of the target site within the body of
the patient.
[0032] Generally, each catheter may be made by any method known in
the art such as extrusion, pultrusion, injection molding, transfer
molding, flow encapsulation, fiber winding on a mandrel, or lay-up
with vacuum bagging. A variety of suitable materials may be used,
so long as each catheter or a portion thereof is sufficiently
flexible for the intended purpose. For example, suitable materials
include surgical stainless steel or biologically compatible metals,
polymers, plastics, alloys (including super-elastic alloys), or
composite materials that are either biocompatible or capable of
being made biocompatible. Flexible sections of the catheters may be
made of any suitable material (natural, synthetic, plastic, rubber,
metal, or combination thereof) that is strong yet flexible and
resilient.
[0033] For portions of each of the catheters that may contact the
patient, the material of construction may need to be biocompatible
or capable of being made biocompatible, such as by coating,
chemical treatment, or the like. Optionally, a thin PTFE heat
shrinkable material may coat the catheter. The heat shrinkable
nature of these materials may facilitate manufacturing and may
provide a lubricious coating to facilitate navigation of the
catheter within the body of the patient. The thickness of the
coating may vary between about 0.01 mm and about 0.20 mm. In
another embodiment, the coating thickness may vary between about
0.01 mm and about 0.05 mm In yet another embodiment, the coating
thickness my vary between about 0.01 mm and about 0.02 mm. These
thicknesses may provide suitable coatings while not adding
significantly to the overall thickness of the catheter. The coating
may be applied to substantially all or a portion of the length of
the catheter. With or without PTFE coating, the catheter or an
insertion portion thereof may be treated with a hydrophilic coating
or hybrid polymer mixture. Such materials may include any suitable
polyvinyl puroladine and cellulose esters in organic solvent
solutions. These solutions may make the catheter surface
particularly lubricious when in contact with body fluids, which may
aid in navigation.
[0034] Radiopaque materials and markers such as bismuth or gold may
be added to the coating. Also, various portions of each of the
catheters (e.g., the distal ends 23, 43 and/or the distal end of
the articulable nozzle 65) may include radiopaque materials and
markers. Several examples of suitable radiopaque materials and
markers are known in the art, and any suitable material and/or
marker can be used with the various embodiments of this
disclosure.
[0035] FIG. 2 depicts another embodiment of the thrombectomy system
110. The occlusion catheter 140 further can include at least one
nozzle port 146 formed in the body 141 at the distal end 143
thereof. The aspiration catheter 60 further can be slidably
received within the occlusion lumen 144 of the occlusion catheter
140. The thrombectomy catheter 20, occlusion catheter 140, and
aspiration catheter 60 may be in a coaxial relationship that may
form a smaller delivery profile. The articulable nozzle 65 of the
aspiration catheter 60 can be extendable through the nozzle port
146 of the occlusion catheter 140 to aspirate thrombus material
from the isolated region 102 of the body vessel 100 as further
described herein. The embodiment of FIG. 2 may assist a clinician
in navigating the distal ends of the occlusion and aspiration
catheters to the desired position. For example, the occlusion
catheter may be navigated through a valve member 121 as shown in
FIG. 2. Once the leaflets of the valve member 121 have been pushed
aside by the occlusion catheter, the aspiration catheter may be
positioned distally of the valve member without further disturbing
the leaflets of the valve member. Such an embodiment also may allow
the occlusion catheter and the aspiration catheter to be navigated
through the body vessel together, e.g., with the aspiration
catheter disposed within the occlusion catheter, to save time
during a thrombectomy procedure.
[0036] FIG. 3 depicts another embodiment of the aspiration catheter
260 that can include a plurality of tubular bodies. In one example,
the aspiration catheter 260 can include a first generally tubular
body 261a and a second generally tubular body 261b; however, more
than two tubular bodies such as three, four, or more are further
contemplated. Each of the first and second bodies 261a, 261b can
have a proximal end and a distal end 263a, 263b, respectively. The
bodies 261a, 261b can be disposed adjacent to one another in a
side-by-side configuration such that each one of the bodies can be
in abutting contact with the other at an outer surface of the body.
Each of the bodies 261a, 261b can be joined to the other along at
least a portion of the outer surface of the body. Additionally,
each of the bodies 261a, 261b may be joined to the other along
substantially an entire length of the body between the proximal end
and the distal end of the body. The first aspiration lumen 264a can
extend longitudinally within the body 261a. Likewise, the second
aspiration lumen 264b can extend longitudinally within the body
261b. Alternatively, the aspiration catheter 260 may include a
single tubular body, e.g., the body 61 as shown in FIG. 1a, having
the second aspiration lumen 264b disposed adjacent to the first
aspiration lumen 264a within the single body of the aspiration
catheter.
[0037] In FIG. 3, the aspiration catheter 260 can include a first
articulable nozzle 265a and a second articulable nozzle 265b. A
first nozzle lumen 266a of the first articulable nozzle 265a can be
in communication with the first aspiration lumen 264a of the
aspiration catheter 260. The first nozzle lumen 266a may terminate
in an end opening 267a. Similarly, a second nozzle lumen 266b of
the second articulable nozzle 265b can be in communication with the
second aspiration lumen 264b and may terminate in an end opening
267b. The aspiration lumens 264a, 264b may be in communication with
one another such that a negative pressure may be applied, as
further described herein, to both lumens simultaneously from a
common source. Alternatively, the aspiration lumens 264a, 264b may
not be in communication with one another such that the same or
different negative pressures may be applied separately to each of
the aspiration lumens . The aspiration catheter 260 further can
include a first means for manipulating the articulable nozzle 265a
and a second means for manipulating the articulable nozzle 265b.
The first and second articulable nozzles 265a, 265b may be
manipulated and/or articulated, as described herein, to aspirate
the isolated region 102 of the body vessel 100.
[0038] Although the system has been described in connection with
its primary intended use for removing thrombus material from an
isolated region of a body vessel, those skilled in the art will
appreciate that the system may also be used in other applications
where accurately controllable aspiration of a specific location
within the body may be desirable.
[0039] FIGS. 4a-4h illustrate a method of removing thrombus
material from an isolated region of a body vessel. The method can
be used, for example, to aspirate thrombus material that can be
partly or completely occluding a body vessel such as a vein and/or
thrombus accumulation that can be disposed in an area between a
body vessel valve or structure, such as a venous valve and a vein
wall. Although reference will be specifically made to a vein and a
venous valve, it can be appreciated that the method can be used for
other vessels and vessel structures. Although the method will be
described with reference to the embodiment illustrated in FIG. 2,
it can be appreciated that the method may be practiced using other
embodiments described herein and/or variations thereof.
[0040] In FIG. 4a, the distal end 23 of the thrombectomy catheter
20 can be inserted percutaneously into a vein 120. Optionally, a
dilator and/or introducer, (not shown) may be used to aid in
inserting the thrombectomy catheter as is well known in the art.
The distal end 23 of the thrombectomy catheter 20 can be translated
distally through the vein 120 to position the distal end proximate
to and distal of a venous valve 121 and proximal of a thrombus
material 202. Optionally, a guide wire (not shown) may be used to
aid in advancing and/or positioning the thrombectomy catheter
within the vein as is well known in the art. In FIG. 4b, the first
occlusion member 26 can be expanded from the non-expanded
configuration to the expanded configuration to sealably engage a
wall 122 of the vein 120. Expansion of the first occlusion member
26 may occlude the vein 120 to substantially inhibit fluid flow
therethrough, and preferably the passage of thrombus debris
proximal of the first occlusion member.
[0041] In FIG. 4c, the occlusion catheter 140 can be inserted into
the thrombectomy lumen 24 of the thrombectomy catheter 20.
Optionally, the occlusion catheter 140 may be inserted into the
thrombectomy lumen 24 of the thrombectomy catheter 20 prior to
insertion of the thrombectomy catheter into the body of the
patient. Such a procedure may eliminate the need to insert the
thrombectomy and occlusion catheters separately into the body of
the patient to reduce the amount of time required to complete the
method according to this disclosure. The occlusion catheter 140 can
be advanced distally through the thrombectomy catheter 20 and the
vein 120 to position the distal end 143 of the occlusion catheter
140 proximate to and distal of the thrombus material 202.
[0042] In FIG. 4d, the distal tip of the occlusion catheter 140 may
pierce through the thrombus material 202 to reach a position distal
of the thrombus material. It is contemplated that the distal tip of
the occlusion catheter may be configured for piercing the thrombus
material. To this end, the distal tip of the occlusion catheter can
have a beveled or pointed tip. Alternatively, the distal tip of the
occlusion catheter 140 may pass through a space between the
thrombus material 202 and the wall 122 of the vein 120 to reach the
position distal of the thrombus material. The second occlusion
member 145 can be expanded from the non-expanded configuration to
the expanded configuration to engage the wall 122 of the vein 120.
Expansion of the second occlusion member 145 may occlude the vein
120 to substantially inhibit fluid flow therethrough, and
preferably the passage of thrombus debris distal of the second
occlusion member. Accordingly, a first region 123 of the vein 120
can be isolated between the first occlusion member 26 and the
second occlusion member 145. In this manner, blood, thrombus
material, and/or other fluid or debris can be prevented from
migrating into and/or outside of the first isolated region 123 of
the vein 120. Particularly, any debris that may be generated by
piercing the thrombus material 202 with the distal tip of the
occlusion catheter 140 can be contained within the isolated region
123 of the vein 120. Negative pressure can be applied to the
thrombectomy lumen 24 at the proximal end of the thrombectomy
catheter 20 to create a suction pressure at the end opening 25
thereof for removal of the thrombus material 202 and/or other
debris. Such negative pressure may be applied by any means known in
the art. For example, negative pressure may be applied using a
syringe. The syringe may be coupled to an adapter (e.g., a Luer
lock fitting) at the proximal end of the thrombectomy catheter.
Negative pressure may be applied by retracting a plunger of the
syringe to draw fluid, thrombus material, and/or debris through the
thrombectomy lumen of the thrombectomy catheter and into a tube of
the syringe. Negative pressure also may be applied using a suction
device employing, for example, a bulb and tube arrangement, a hand
pump, and/or a diaphragm pump. Other suction devices will be
apparent to those having ordinary skill in the art.
[0043] In FIG. 4e, after the initial removal of the thrombus
material and/or debris with the thrombectomy catheter 20, the
occlusion catheter 140 may be moved relative to the distal end 23
of the thrombectomy catheter 20, such as by retraction of the
second occlusion member 145 proximally toward the distal end 23 of
the thrombectomy catheter. The thrombus material 202 can be urged
proximally by such proximal movement of the second occlusion member
145. Additionally, the thrombus material 202 can be urged into the
end opening 25 of the thrombectomy catheter 20 by the suction
created therein. Accordingly, the thrombus material 202 and/or
debris can be aspirated and removed from the vein 120 through the
thrombectomy lumen 24 of the thrombectomy catheter 20.
[0044] The first occlusion member 26 can be moved from the expanded
configuration to the non-expanded configuration to disengage from
the wall 122 of the vein 120 as shown in FIG. 4f. In FIG. 4g, the
thrombectomy catheter 20 may be moved relative to the occlusion
catheter 140, such as by retraction of the thrombectomy catheter to
position the distal end 23 proximate to and proximal of the venous
valve 121. The first occlusion member 26 can be moved from the
non-expanded configuration to the expanded configuration to
sealably engage the wall 122 of the vein 120 to isolate a second
region 124. The venous valve 121 may be disposed within the second
isolated region between the first occlusion member and the second
occlusion member. The second isolated region 124 may extend
proximal of and substantially overlap with the first region
123.
[0045] In FIG. 4h, the aspiration catheter 60 can be inserted into
the occlusion lumen 144 of the occlusion catheter 140. The
aspiration catheter 60 can be advanced distally through the
occlusion catheter 140, the thrombectomy catheter 20, and the vein
120 to position the distal end 63 of the aspiration catheter
adjacent to the nozzle port 146 of the occlusion catheter 140. The
articulable nozzle 65 can be manipulated as described herein to
extend through the nozzle port 146 and into the second isolated
region 124. The articulable nozzle 65 can be manipulated and/or the
aspiration catheter 60 can be translated and/or rotated as
described herein to position the end opening 67 of the articulable
nozzle 65 proximate to a thrombus accumulation 204 disposed in a
space between the venous valve 121 and the wall 122 of the vein
120. The position of the aspiration catheter 60 within the
occlusion catheter 140 can be adjusted and/or the means for
manipulating the articulable nozzle 65 can be operated to position
the end opening 67 of the aspiration catheter 60 as desired.
Negative pressure can be applied to the aspiration lumen 64 of the
aspiration catheter 60 to create a suction pressure at the end
opening 67 thereof. Such negative pressure may be applied by any
means known in the art as described with respect to the
thrombectomy catheter. A device for applying negative pressure may
be coupled to an adapter (e.g., a Luer lock fitting) at the
proximal end of the aspiration catheter. The same device may be
used to apply negative pressure to the thrombectomy catheter and
the aspiration catheter. Alternatively, different devices may be
used. The thrombus accumulation 204 can be urged into the end
opening 67 of the aspiration catheter 60 by the suction pressure
created therein. Accordingly, the thrombus accumulation 204 can be
aspirated and removed from the vein 120.
[0046] It can be appreciated by those skilled in the art that
specific features of each embodiment of the system and/or method
are interchangeable among the various embodiments, even where no
references to the specific features are made.
[0047] Drawings in the figures illustrating various embodiments are
not necessarily to scale. Some drawings may have certain details
magnified for emphasis, and any different numbers or proportions of
parts should not be read as limiting, unless so-designated in the
present disclosure. Those of skill in the art will appreciate that
embodiments not expressly illustrated herein may be practiced
within the scope of the present invention, including those features
described herein for different embodiments, and may be combined
with each other and/or with currently-known or future-developed
technologies while remaining within the scope of the claims
presented here. It is therefore intended that the foregoing
detailed description be regarded as illustrative rather than
limiting. And it should be understood that the following claims,
including all equivalents, are intended to define the spirit and
scope of this invention.
* * * * *